1. International Standards and Organizations
Day 3 – Lecture 5

2. Objective
To explain the role of international organizations and to present the main IAEA standard in the field of radiation safety.

3. Contents
The International Commission on Radiological Protection (ICRP) and Publication 103.
Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (GSR Part 3).
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4. Relevant International Organizations
The International Commission on Radiological Protection (ICRP)
has established fundamental radiation protection principles and recommendations.
The International Commission on Radiation Units and Measurement (ICRU)
Several international organizations are concerned with the promotion of radiation protection. The prime organization is the International Commission on Radiological Protection (ICRP) which together with its sister organization the International Commission on Radiation Units and Measurements (ICRU), was established in 1928 by the second International Congress of Radiology. The United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) regularly reviews the current status on the human radiation environment and the current knowledge of radiation effects and radiation risks. The work of UNSCEAR is an important base for the recommendations of the ICRP and the program of the international organizations.
The ICRP and the ICRU were established in 1928 by the Second International Congress of Radiology.

5. Relevant International Organizations (cont)
United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR)
undertakes regular reviews of the current:
status on the human radiation environment;
knowledge of radiation effects and radiation risks.
and is an important information base for:
the recommendations of the ICRP;
programs of the international organizations.

6. Relevant International Organizations (cont)
The functions of the International Atomic Energy Agency (IAEA) include:
verifying the peaceful uses of atomic energy;
promoting safety;
enabling the transfer of technology;
establishing standards of safety and to provide for their application;
facilitating the establishment of conventions.

7. Other Organizations Food and Agricultural Organization (FAO)
International Labour Organization (ILO)
World Health Organization (WHO)
Nuclear Energy Agency of the OECD (NEA)
Pan American Health Organization (PAHO)

8. ICRP Background
During the early years of diagnostic radiology, a large number of severe overexposures and radiation accidents occurred.
A growing number of acute radiation exposure incidents led to recommendations on radiation protection in the international literature.
The ICRP was established in 1928 by the Second International Congress of Radiology.

9. ICRP Recommendations are:
formulated in different areas of radiation protection, are based on current knowledge about the biological effects of ionizing radiation and are revised on regular basis;
generally adopted by regulatory bodies and advisory agencies at national and international levels as the basis for the development of legislation, regulations, codes of practice and guidelines.
The ICRP is a non-political organization. Its members are elected on the basis of well-recognized work in radiation protection and related fields.

10. ICRP Recommendations Annals of the ICRP ICRP Publication 103
The 2007 Recommendations of the International Commission on Radiological Protection.
Annals of the ICRP
ICRP Publication 103
Volume 37. No
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ICRP 60 sets out the basic occupational and public dose limits

11. ICRP 103 Recommendations
The general purposes of radiation protection are to:
prevent detrimental deterministic effects such as erythema, cataract, etc.;
limit the probability of stochastic effects, such as cancer and hereditary effects, to levels deemed to be acceptable.
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12. ICRP 103 Recommendations (cont)
Situation-based approach applying fundamental principles to all controllable exposure situations:
three exposure situations:
Planned exposure situation
Emergency exposure situation
Existing exposure situation
NEW

13. ICRP 103 Recommendations (cont)
Commission’s extensive review of health effects of ionizing radiation has not indicated that any fundamental changes are needed to the system of radiological protection.
The fundamental principles of radiation protection still are:
justification;
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optimization of protection;
dose limitation.

14. Justification Justification 1
Any decision that alters the radiation exposure situation should do more good than harm
It applies to all 3 exposure situations
Note 1: The principles may have different wording but are the same as in IAEA publications
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In developed countries, medical uses of radiation contribute the highest radiation dose to the population from man-made sources. Although health programs with the potential to exposure large populations (eg chest screening or mammography) may be thoroughly investigated and the exposures justified against the radiation risk, it is questionable that many medical practitioners referring individual patients for examinations involving ionizing radiation consider this question and acitvely consider non-ionzing radiation alternatives.

15. Optimization
The likelihood of incurring exposure, the number of people exposed, and the magnitude of their individual doses should all be kept As Low As Reasonably Achievable, taking into account economic and societal factors.
It applies to all 3 exposure situations
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16. Optimization (cont)
The process should be constrained by restrictions on:
the doses to individuals (dose constraints), or
the risks to individuals in the case of potential exposures (risk constraints),
so as to limit the inequity likely to result from the inherent economic / social judgements

17. Dose Limitation
The total dose to any individual from regulated sources in planned exposure situations other than medical exposure of patients should not exceed the appropriate limits specified by the Commission.
All the dose limits are the same as in ICRP-60 except the dose limits for lens of eye for workers and apprentices that have been reduced
Dose limitation only applies to planned exposure situations
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18. Dose Limitation (cont)
Dose limits:
are aimed at ensuring that no individual is exposed to radiation risks that are judged to be unacceptable;
differ depending on whether the exposure is to workers or to members of the public;
do not apply to medical exposure where the issue is the intended result in terms of diagnosis or treatment.

19. IAEA Safety Standards Fundamentals
underlying principles - directed at senior politicians and regulators
Requirements
specify obligations and responsibilities
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Guides
recommendations in support of the requirements, based on international experience

20. Basic Safety Standards
The International Basic Safety Standards for Protection Against Ionising Radiation and for the Safety of Radiation Sources (BSS) are jointly formulated and sponsored (expected by end 2012) by the:
Food and Agriculture Organization of the United Nations (FAO);
International Atomic Energy Agency (IAEA);
International Labour Organization (ILO);
Nuclear Energy Agency of the OECD (NEA);
Pan American Health Organization (PAHO), and
World Health Organization (WHO).
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21. Basic Safety Standards (BSS) – GSR Part 3
Background
First BSS 1962
Revised 1967
Revised, joint sponsorship with
FAO, ILO, OECD / NEA, PAHO,
WHO 1982
ICRP Publication
SS 115 published 1996
ICRP Publication
GSR Part 3 Interim
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22. Basic Safety Standards (GSR Part 3)
The recommendations contained in ICRP Publication 103 have been incorporated into GSR Part 3.
The Standards were established to assist appropriate Regulatory Bodies to organize and implement an adequate radiation and waste safety infrastructure, together with the necessary regulatory infrastructure.
The Standards were also formulated to provide general guidance for organizations representing employers or workers.
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23. Basic Safety Standards (GSR Part 3) - Scope
The Standards apply to the three exposure situations:
carried out in States that adopt the GSR Part 3;
undertaken by States with the assistance of FAO, IAEA, ILO, PAHO, WHO;
carried out by IAEA or with materials etc. from IAEA;
where parties to bi / multi-lateral arrangements request the application of the GSR Part 3.
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24. Objectives of a Regulatory System
The type of regulatory system adopted in a country depends on:
its size;
the complexity and safety implications of the regulated practices and sources;
the regulatory traditions in the country.

25. Objectives of a Regulatory System (cont)
The general functions of a Regulatory Body include:
assessment of notifications for permission to conduct practices that entail or could entail exposure to radiation;
authorization of relevant practices and the sources associated with them, subject to specified conditions;
periodic inspection for compliance with conditions; and
enforcement as necessary to ensure compliance with regulations and standards.
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26. Objectives of a Regulatory System (cont)
Mechanisms are needed for:
notification of intended radiation uses;
registration of relevant low risk practices;
licensing of other practices, with
MODIFIED
provision for the exemption of sources or practices from regulatory requirements under certain conditions.

27. Objectives of a Regulatory System (cont)
Provision is also needed for:
surveillance, monitoring, review, verification and inspection of sources, and for
ensuring that adequate plans exist for dealing with radiation accidents and emergency situations.
MODIFIED
The effectiveness of radiation protection and safety measures for each authorized source should be assessed, as should the total potential health and environmental impact of all authorized sources.

28. System of Radiation Protection
An efficient combination of:
administration and
organization
is needed for achieving the objectives of radiation protection.
An adequate infrastructure for radiation protection is necessary at all levels within:
each country;
facilities using radiation;
departments within facilities (e.g. universities, hospitals, etc.)

29. System of Radiation Protection (cont)
Infrastructure for radiation protection should be based on:
a safety culture;
a safety-based attitude; and
recommendations from international organizations along with the requirements of the national Regulatory Bodies.
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30. Essential National Infrastructure
Legislation (Act, Statute, Decree, etc)
Regulations
A Regulatory Body:
to authorize, review and assess radiation use;
to inspect practices and enforce the legislation; and
with appropriate resources and trained personnel.
MODIFIED
General provisions /services
education and training of users and Regulatory Body staff
personal dosimetry, calibration, other monitoring, etc

31. GSR Part 3 Contents MODIFIED 1. INTRODUCTION
2. GENERAL REQUIREMENTS FOR PROTECTION AND SAFETY
Application of principles of radiation protection
Responsibilities of the government
Responsibilities of the regulatory body
Responsibilities for protection and safety
Management requirements
3. PLANNED EXPOSURE SITUATIONS
Scope
Generic requirements
Occupational exposure
Public exposure
Medical exposure
4. EMERGENCY EXPOSURE SITUATIONS
Exposure of emergency workers
Transition from an emergency exposure situation to an existing exposure situation
5. EXISTING EXPOSURE SITUATIONS
Schedule I EXEMPTION AND CLEARANCE
Schedule II CATEGORIZATION FOR SEALED SOURCES USED IN COMMON PRACTICES
Schedule III DOSE LIMITS FOR PLANNED EXPOSURE SITUATIONS
Schedule IV CRITERIA FOR USE IN EMERGENCY PREPAREDNESS AND RESPONSE
103
The 2007 Recommendations of the International Commission on Radiological Protection
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32. Schedules I Exemptions and Clearance. .
II Categorization for sealed sources used in common practices.
III Dose limits for planned exposure situations.
IV Criteria for use in emergency preparedness and response
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33. Definitions
Practice
Any human activity that introduces additional sources of exposure or additional exposure pathways, or modifies the network of exposure pathways from existing sources, so as to increase the exposure or the likelihood of exposure of people or the number of people exposed
Licence
A legal document issued by the Regulatory Body granting authorization to perform specified activities relating to a facility or activity.
Licensee
The holder of a current Licence.
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34. Definitions (cont) 1 Planned exposure situation
A situation of exposure that arises from the planned operation of a source or from a planned activity that results in an exposure from a source.
Emergency exposure situation
An situation of exposure that arises as a result of an accident, a malicious act, or any other unexpected event, and requires prompt action in order to avoid or reduce adverse consequences.
Existing exposure situation
A situation of exposure that already exists when a decision on the need for control needs to be taken.
Note 1: More definitions available in GSR Part 3 and in IAEA Safety Glossary
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35. Responsibilities
Responsibilities for implementing requirement assigned to:
Government
Regulatory body or other national authority
Registrant and licensee (main responsibility for application of Standards)
Employers
Radiological medical practitioner
Manufacturers and other suppliers
Providers of consumer products
Emergency response organizations
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36. Application of the GSR Part 3
Practices
Production and supply of r/a material & devices that generate radiation; generation of NP and other activities in nuclear fuel cycle; use of radiation or r/a material for industry, medical etc; mining and processing or raw materials
Sources with practices
Facilities that contain r/a material / radiation generators e.g. nuclear installation, medical radiation facilities, r/a waste management facility, mineral extraction & mineral processing facilities
Individual sources of radiation
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37. Application of the GSR Part 3 (cont)
Occupational, medical and public exposure
Natural sources
Material containing natural radionuclides above specified level :
(U/Th decay chains > 1 Bq/g; K-40 > 10 Bq/g)
Radon (Rn-220 and Rn-222) and their progeny
(i) in workplace where radon levels above reference level
(ii) in workplaces where r/nuclides in U/Th chains are above 1 Bq/g
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38. Application of the GSR Part 3 (cont)
Planned exposure situations
Occupational exposures
The GSR Part 3
applies to
Emergency exposure situations
Public exposures
MODIFIED
Existing exposure situations
Medical exposures

39. Notification and Authorization (Req. 7)
Any person or organization intending to operate a facility or to conduct an activity shall submit to the regulatory body, as appropriate, a notification or an application for authorization.
3.7 Notification alone is sufficient provided that the exposures expected to be associated with the practice or action are unlikely to exceed a small fraction, as specified by the regulatory body, of the relevant limits, and that the likelihood and magnitude of potential exposures and any other potential detrimental consequences are negligible.
3.7 Notification is required for consumer products only with respect to manufacture, assembly, maintenance, import, distribution and, in some cases, disposal.
MODIFIED

40. Authorization: registration or licensing (Req. 7)
3.8. Any person or organization intending to carry out any of the actions specified in para. 3.5 (adopt, introduce, conduct, discontinue or cease a practice, or as applicable, mine, extract, process, design, manufacture, construct, assemble, install, acquire, import, export, distribute, loan, hire, receive, site, locate, commission, possess, use, operate, maintain, repair, transfer, decommission, disassemble, transport, store or dispose of a source) shall, unless notification alone is sufficient, apply to the regulatory body for authorization, which shall take the form of either registration or licensing.
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41. Registration (Req. 7) Typical practices amenable to registration:
safety largely ensured by design facilities and equipment;
operating procedures simple to follow;
safety training requirements minimal;
there is history of few problems with safety in operations.
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Registration best suited to practices for which operations do not vary significantly

42. Exemption and Clearance (Schedule I)
A practice or radiation source may be exempted if:
the individual public effective dose is <10 µSv in a year; and the effective dose expected to be incurred by any member of the public for such low probability scenarios does not exceed 1 mSv in a year;
Or regulatory control of the practice or the source would yield no net benefit, in that no reasonable control measures would achieve a worthwhile return in terms of reduction of individual doses or of health risks.
MODIFIED
For radioactive substances, either the total activity or the activity concentration is to be less than the levels specified in Schedule I.

43. Radiation Protection Requirements for Practices
Justification of practices (the radiation use has a positive net benefit).
Dose limitation (dose limits are applied) for occupational and public exposures.
Optimization of protection and safety (ALARA) by the application of:
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dose constraints;
guidance levels for medical exposure.

44. Safety assessment (Req. 13)
The Regulatory Body shall establish and enforce requirements for safety assessment, and the person or organization responsible for a facility or activity that gives rise to radiation risks shall conduct an appropriate safety assessment of this facility or activity.
Safety assessments must be undertaken to:
identify normal and potential exposure routes;
determine the magnitude and likelihood of exposures (normal operation and potential exposures);
assess protection and safety provisions.
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45. Monitoring for verification of compliance (Req. 14)
Monitor and measure parameters to assess compliance with the requirements for protection and safety:
using appropriate and calibrated monitoring equipment;
maintaining and testing verification procedures;
recording results;
results of monitoring and verification of compliance are shared with the regulatory body as required.
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46. Graded approach (Req. 6)
The application of the requirements in planned exposure situations shall be commensurate with the characteristics of the practice or the source within a practice, and with the magnitude and likelihood of the exposures.
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47. Management for protection and safety (Req. 5)
The principal parties shall ensure that protection and safety is effectively integrated into the overall management system of the organizations for which they are responsible.
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48. Interface between safety and security
1.41: reference to nuclear security series of publications.
2.27: The government shall ensure that infrastructural arrangements are in place for the interfaces between safety and security of radioactive sources.
3.32: The safety assessment shall include: (f) the implications for protection and safety of security measures, and of any modifications to security measures.
MODIFIED